Ileostomy Infusion for Ileostomy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to prepare the intestines for surgery to reverse an ileostomy, where part of the intestine is diverted to an external bag. The approach involves returning the contents from the ostomy bag into the intestine before surgery to help the intestines adjust and function normally more quickly after the operation. Individuals with a diverting loop ileostomy planning for reversal might be suitable candidates. Participants will either receive the ileostomy infusion treatment or join a control group with no intervention. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that this ileostomy infusion is safe?
Research has shown that the safety of ileostomy infusion remains under investigation. This treatment involves returning the contents of an ostomy bag to the intestine before surgery. Unfortunately, specific information on its safety for individuals is limited.
The trial is in an early stage, so researchers primarily focus on assessing its safety. During this phase, they closely monitor for any side effects or problems. Major safety issues would prevent the treatment from advancing beyond this stage.
Prospective participants should know that early trials like this are carefully monitored. Researchers closely observe participants to manage any side effects promptly. Consulting a doctor is crucial to understand the risks and benefits before joining a trial.12345Why are researchers excited about this trial?
Researchers are excited about the ileostomy infusion technique because it offers a new approach to managing patients with an ileostomy before a takedown operation. Unlike traditional methods that don't involve direct intervention, this technique involves infusing the ileostomy to potentially improve outcomes and prepare the site more effectively. This infusion approach could lead to better healing and fewer complications post-surgery, which would be a significant advancement over current practices.
What evidence suggests that ileostomy infusion is effective for retraining the intestine before takedown surgery?
Research has shown that returning the contents from an ostomy bag into the intestine might help prepare the intestine for surgery to reverse the ostomy. This method allows the intestine to "practice" handling waste again, which is beneficial because the intestine might struggle to function properly after prolonged inactivity. In this trial, participants will either receive the ileostomy infusion or join a control group with no intervention. A study comparing early and late ileostomy closures found that earlier closure led to shorter surgeries and less bleeding. This suggests that starting this process sooner could be advantageous. While researchers continue to study the infusion method, the aim is to make recovery after the reversal surgery smoother and faster.678910
Are You a Good Fit for This Trial?
This trial is for individuals with a temporary loop ileostomy who are preparing for an operation to reverse the ostomy. Participants must be able to infuse contents from their ostomy bag back into their intestine and give consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Intestinal Training
Participants undergo infusion of contents from the ostomy bag back into the intestine to re-train them prior to the ostomy takedown operation
Surgery and Immediate Recovery
Participants undergo the ostomy takedown operation and are monitored for the return of bowel function
Follow-up
Participants are monitored for complications and ease of stoma infusion post-surgery
What Are the Treatments Tested in This Trial?
Interventions
- Ileostomy Infusion
Trial Overview
The study tests whether infusing intestinal contents from an ostomy bag back into the intestine before surgery can re-train the bowel and help it recover normal function faster after the reversal operation.
How Is the Trial Designed?
2
Treatment groups
Active Control
perform infusion if ileostomy prior to takedown operation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
Citations
Postoperative Outcomes of Stoma Takedown
Perioperative outcomes are shown in Table 2. The time from stoma formation to takedown was 5.3 months. Most of the patients underwent an ileostomy rather than ...
Outcome of early versus late ileostomy closure in patients ...
Patients undergoing early closure of the ileostomy had significantly shorter operation duration (p<0.001) and intraoperative bleeding (p<0.001) compared to late ...
Meta-analysis of early versus late closure of a temporary ...
A systematic review showed that closure of a temporary ileostomy was associated with low mortality (0.4%), but overall morbidity following a ...
Early vs. standard reversal ileostomy: a systematic review ...
A systematic review of the current randomised controlled trial literature comparing early and standard ileostomy closure after rectal surgery was performed.
Postoperative Morbidity Following Loop Ileostomy ...
The overall morbidity rate after ileostomy closure is approximately 20% [9,22], and small bowel obstruction is the most common complication [23, ...
Management of complications in patients with an ileostomy
Using sensor-based smart wearables and information technology, patients can better manage and control the ostomy and reduce its complications.
Protocol-Based Intravenous Fluid Hydration for Newly ...
Standardized, mandatory at-home intravenous hydration following ileostomy creation leads to a significant reduction in postoperative incidence of dehydration.
Risk factors for readmission with dehydration after ...
The primary outcome was the pooled risk ratio of clinically relevant variables potentially associated with dehydration-related readmission ...
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perioperativemedicinejournal.biomedcentral.com
perioperativemedicinejournal.biomedcentral.com/articles/10.1186/s13741-021-00226-zRisk factors and outcomes associated with postoperative ileus ...
Postoperative ileus (POI) is associated with increased patient discomfort, length of stay (LOS), and healthcare cost.
NCT04669964 | Evaluating Ileostomy Hydration Protocol
This is a prospective observational study on patients who undergo an ileostomy creation after implementing a hydration algorithm as routine care at Robert ...
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